• Facebook
  • Twitter

Frequently Asked Questions

1. What is accreditation?

Accreditation is generally a voluntary process by which formal recognition that a body or person is competent to carry out specific tasks is conferred by an authoritative body. It shows clients – current and potential – that a laboratory meets world-class standards of excellence and gives international recognition to the laboratory.

2. What do we mean when we say that a medical laboratory is accredited?

We mean that the lab is competent to perform the specific tests included in its scope of accreditation and also that its quality system meets the requirements of a recognized standard such as, for example, the ISO 15189 standard.

3. Why should medical laboratories be accredited?

Being accredited ensures that laboratories remain current and on top of new technology. Accreditation encourages continuous improvement of the services offered and allows staff and clients to have confidence in the technical capability of the laboratory. Clients of an accredited laboratory can be assured of receiving a reliable, timely and relevant service. Accreditation can also be used to market a laboratory’s services.

4. Who are the major beneficiaries of medical laboratory services?

The staff and clients of the accredited laboratory, including governments and the general public, benefit significantly from the high quality services guaranteed by an accredited laboratory. The insurance and tourism industries are also major beneficiaries of high quality laboratory services.

5. Is medical laboratory error a common occurrence?

Laboratory error is more common than many users think. There is growing concern globally about medical laboratory error and more aggressive efforts to control error have been introduced. Most errors occur in the pre and post-analytic phases of testing i.e before and after the actual test is conducted. Although generally not recognized, the testing process is a very complex one and errors can be made at any of the many steps of the process. The Institute of Medicine’s 1999 report “to Err is Human” estimated that as many as 98,000 people died each year from preventable medical error. This included medical laboratory error. Continuous monitoring and tracking of error is critical to reliable laboratory services.

6. How does medical laboratory error impact?

Medical laboratory error can lead to wrong diagnoses and wrong treatment that can ultimately lead to prolonged illness or even death. Since many health and life insurance decisions are based on laboratory information, incorrect test data can prevent access to insurance services and can also significantly increase client and industry costs. The Caribbean region is one of the most tourism dependent regions in the world and laboratory errors can negatively impact the industry as well as national and regional economies, through failure to identify agents of disease outbreaks or failure to appropriately manage visitors seeking medical care. Additionally, health decisionmakers often use laboratory data to inform health policy development and this can be easily skewed if wrong information is supplied.

7. Is medical laboratory information critical to medical decision making?

It is estimated in North America that upwards of 70 % of medical decisions are dependent on medical laboratory information.

8. Is there a quality standard or benchmark for medical laboratory operations?

Prior to 2003, a generic standard for laboratories, the ISO 17025 was used to evaluate laboratory operations. In 2003 a special standard or benchmark for medical laboratories, the ISO 15189 was introduced. This has been adopted in the Caribbean as the benchmark for medical laboratory operations.

9. Can medical laboratories deliver a high quality service without the assistance of other key persons?

Fortunately or unfortunately, lab business is everybody’s business. Laboratory functioning is truly a team operation. Without the compliance and support of governments or owners who supply the needed resources; clinicians who prepare the patients, observe the requirements of the standard for the collection and transport of samples, interpret the laboratory’s results correctly; patients or clients who follow clinician or laboratory instructions; service providers such as procurement, maintenance and proficiency testing agents who comply with the requirements of the standard etc., the laboratory will never be able to satisfy the quality requirements of the ISO 15189 standard.

10. Is medical laboratory information used only for patient care?

Medical laboratory information is used to manage patients effectively but is also used for the control and prevention of disease, the management of disease outbreaks, the tracking of disease patterns and the development of health policy. Very important is the utilisation of lab information to manage laboratory operations cost-effectively and efficiently.

11. Should you only use a laboratory that is accredited?

Accredited laboratories should be used where possible as this signals that a lab is competent to offer the services that it does. In the accreditation process, specialist assessors conduct a thorough evaluation of systems, people, infrastructure, equipment, services and customer satisfaction. If access to an accredited laboratory is limited then you must ask questions about the quality management practices within the laboratory you wish to use e.g quality control practices, proficiency testing participation, internal auditing practices, inventory management, staff training programmes, equipment maintenance programmes etc.

12. What should you consider when choosing a laboratory?

Ask questions and observe carefully. The technical competence of the laboratory depends on well trained and appropriately skilled staff; properly maintained equipment; proper sampling techniques; up-to-date, relevant and appropriate technology; use of proven valid methods; ability of the lab to trace measurements to some recognized standard; effective recording and reporting procedures; focus on customer service including timeliness and good customer relations and of course the competitive costing of services.

13. Is there a cost to non-compliance with the benchmark standard?

In a study conducted by the Health Economics Unit and CAREC in the late 1900s. on the cost of implementing quality ( or not) for HIV testing, it was estimated that the cost of NOT implementing quality was some $US 7 million/yr. Apart from which, in countries where accreditation or a specific standard is required by law, a laboratory can be closed and all business lost.

14. Why is a laboratory’s technical competence critical to manufacturers, suppliers or exporters?

A competent laboratory reduces the risk of supplying faulty products. Additionally, using a laboratory that guarantees high quality service avoids the cost, in both money and time,  of retesting. Apart from losing business, the supplier runs the risk of losing credibility.

15. How does an accredited laboratory benefit government regulators

Governments have accepted responsibility for protecting the public’s health and wellbeing, protecting the environment, enforcing health regulations and ensuring compliance. When governments use an accredited lab they signal the importance they place on standards and the delivery of high quality health care and increase public confidence in medical labs in general. Where governments lead others often follow.

16. How do insurance companies influence laboratory operations?

Insurance companies access services from both the private and public medical laboratory sector in Caribbean countries. In many instances a significant percentage of laboratory income is generated through the provision of services to insurance companies. Insurance companies therefore have tremendous influence in driving medical laboratories towards quality management systems implementation and accreditation simply by establishing criteria for the procurement of medical laboratory services that are linked to compliance with the ISO 15189 Standard.

17. CD4+T-Cell counting technology: What are CD4+ T-cells? What is the CD4+ T-cell count? How are CD4+ T-cells enumerated?

Click here for answers.

18. Viral load testing: What is HIV-1 Viral Load? How are CD4 and HIV viral load used? How is Viral Load measured?

Click here for answers.

19. ELISA tests: What is an ELISA test?

Click here for answers.

20. Simple/Rapid tests: What is a Simple/Rapid test? What is the difference between a ELISA and a Simple/Rapid test?

Click here for answers.

21. Confirmatory assays: What is a Confirmatory Assay?

Click here for the answer.

22. Window period: What is the "window-period" and how long is it?

Click here for the answer.

23. Alternative specimens - whole blood, oral fluid & urine: Is urine or saliva feasible to use as a source of HIV detection?

Click here for the answer.

Login Form

CMLF News Issue #7
27th January 2016